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Rx Drugs

The European Union is trying to break a deadlock in World Trade Organization talks on providing access to generic copies of patented medicines by floating a compromise that uses the World Health Organization to determine the full scope of diseases covered by the new rules. But the United States has signaled that it does not see a need to go beyond the unilateral steps it has taken to address a limited set of grave infectious epidemics like HIV/AIDS after the WTO negotiations on the issue broke down late last year.

Rep. Thomas Allen (D-ME), an outspoken lawmaker on prescription drug pricing, is one of four new House Democrats appointed to the Energy and Commerce Committee. Reps. Janice Schakowsky (IL), Jim Davis (FL) and Hilda Solis (CA) are the other new Democrats on the panel.

The U.S. government will argue both for and against a Maine drug discount program scheduled for Supreme Court review this month. Having successfully petitioned the court to take part in the Jan. 22 hearing, the Office of the Solicitor General will present divided arguments on the Maine Rx plan, said a spokesperson for the federal government's top lawyer.

The drug industry has appealed to the high court over the state's drug law, which would require drug makers to pay Medicaid-priced rebates for drugs sold to all residents, not just those eligible for Medicaid.

Senate Minority Leader Thomas Daschle (D-SD) Jan. 7 unveiled his party's legislative agenda for the 108th Congress, and swiftly introduced Democratic bills to provide Medicare prescription drug coverage, bolster homeland security and expand health care coverage. The Democrats' prescription drug bill would also reform drug patent law and allow reimportation of drugs from Canada -- two proposals passed by the Senate last year but never taken up by the House.

Brand-name drug company Organon says FDA should allow in the Orange Book method-of-use patents that claim unapproved uses of a company's already approved drug. The company maintains that the agency's stance that these patents cannot be listed is at odds with the goals of drug patent law.

Johnson & Johnson wants FDA to require generic drugmakers to provide innovators with samples of generic drugs so that brand-name companies can determine if the generic drugs infringe on their patents. J&J argues that such a requirement would reduce unnecessary patent infringement litigation, and that it is unfair that generic drug companies can sample brand-name products but brand-name companies cannot sample generic products.

The trade associations representing the generic and brand-name drug industries are clashing over FDA's plan to allow drug substance patents that do not claim the drug substance used in the approved drug (such as different crystal forms known as polymorphs) to be listed in the Orange Book. While the generic drug trade association says these patents should not be allowed in the Orange Book, the brand-name drug company says FDA already allows such listings and should acknowledge that it does.

In a surprise move, the generic drug industry trade group has decided to oppose a key element of the president's generic drug reform plan -- a proposal for a single 30-month stay per generic drug application. The Generic Pharmaceutical Association (GPhA) says the administration's 30-month stay proposal, which the White House touts as a move to increase generic drug access, could instead delay generic drug entry.

A key Senate Democrat is rejecting AARP's proposal to use the Medicare Trust Fund to finance a comprehensive prescription drug benefit. The lawmaker's statements will likely end speculation on whether the trust funds will be touched to craft a drug benefit, since GOP House leaders also oppose the funding plan.

With the pharmaceutical industry already promising a fight, Sen. Byron Dorgan (D-ND), chair of a Senate Commerce and Transportation subcommittee, is planning to introduce a bill that would allow pharmacists and wholesalers to reimport drugs from Canada. The bill is likely to reignite controversy over reimportation, as the Pharmaceutical Research and Manufacturers of America (PhRMA) has promised to fight the impending bill, and an FDA source says the agency has safety concerns regarding the approach.

The state of Maine has won round one against a pharmaceutical industry bid to quash the state's prescription drug discount program for low-income residents.

In a Feb. 25 decision, the U.S. District Court for the District of Columbia has ruled in favor of the Healthy Maine Prescription Program (HMP), authorized by HHS to reduce prescription drug costs for needy residents ineligible for Medicaid.

Top House lawmakers are reconsidering their stance on Medicare reform funding and may call for more resources to pay for prescription drug coverage, Medicare+Choice improvements, and provider payment adjustments, according to sources.

Pharmacy groups are "very likely" to resume their legal challenge over President Bush's prescription drug discount card following today's (March 1) release of the administration's revised initiative, according to an industry source.

Members of the two key pharmacy groups that successfully halted the administration's original card plan are meeting today to discuss continuing their court action. A source with one of the groups says the revised card plan is almost identical to the first proposal and therefore, violates the federal court injunction.

In an unprecedented move, AARP will soon ask Congress to dip into the Medicare Trust Fund to finance a $700 billion Medicare reform bill that would mostly pay for a comprehensive prescription drug benefit, according to an AARP source.

AARP is preparing a letter to both the House and Senate budget committees that will propose taking $350 billion from general revenue and $350 billion from the Medicare Trust Fund, according to the source. The letters will likely be sent this week.

A key Senate player in the Medicare prescription drug debate is pursuing increased usage of generic drugs to help cut the cost of a comprehensive drug benefit. Sen. John Rockefeller (D-WV) is examining the potential savings through generics in a bid to save money and increase the chances of enacting a drug benefit this year.

Legislation that would deal with all aspects of Medicare reform, including a prescription drug benefit as well as numerous other Medicare reform language, has a "good chance" of passing by "early summer," according to a GOP source.

A powerful Senate Democrat last week accused the Bush administration of "cooking the books" on its new Medicare funding request, criticizing Bush's proposed budget for lacking enough money for a prescription drug benefit and provider payment adjustments.